Facing omicron 'curveball,' Inovio seeks endpoint switch amid fear it will strike out against original goal Pfizer revs up to leave GSK in the dust as maternal RSV vax granted FDA breakthrough tag FDA slaps hold on Finch's C. diff med to get info on COVID-19 screening for donor-derived therapy Sponsored: The Importance of the Patient in Advancing Care in Rare Diseases Novartis backs Epsilogen's bid to turn 'Cinderella antibody' into new class of cancer drug Sanofi picks a 'safe' bet for Adagene's antibody tech in $2.5B biobucks tie up SAB's shares drop 45% after NIH ditches COVID-19 trial due to waning hospitalizations Flagship unveils Vesalius with $75M to bankroll ambitious target of treating 90% of human illnesses RedHill's 2nd try COVID pill staves off hospitalization in phase 2 Epizyme trims workforce, pipeline for FDA-approved cancer drug Tazverik in cost-saving move Sanofi's net prices keep slipping—despite list price hikes—thanks to billions in rebates BMS, Novartis, Akebia and more face FDA approval decisions soon, with big sales on the line FDA approves J&J’s allergy-fighting contact lens infused with an antihistamine Quanterix links up with Eli Lilly for Alzheimer's blood biomarker testing collaboration Biden presses for capping insulin costs and nursing home reforms in first State of the Union Featured Story | By Nick Paul Taylor The long wait for phase 3 data on Inovio’s COVID-19 vaccine just got longer. With DNA vaccine INO-4800 generating significantly lower antibodies against omicron than original SARS-CoV-2, Inovio has paused enrollment and asked regulators to change the primary endpoint to prevention of severe disease. read more |
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Top Stories By Annalee Armstrong Pfizer already got a major boost for its maternal RSV vaccine this week, when trials for GlaxoSmithKline’s rival shot were halted. And now the FDA has granted Pfizer a breakthrough therapy tag, which could allow the New York pharma to put the pedal to the metal and leave its U.K. peer in the dust. read more By Kyle LaHucik Finch Therapeutics' phase 3 trial for a C. difficile med has been placed on clinical hold by the FDA as the agency requests more information on how the biotech screens the donor-derived microbiome therapy for the virus that causes COVID-19. read more Sponsored by: Ipsen Read more to learn about Ipsen's commitment to the rare disease community and to ensuring their patients have a voice. read more By Nick Paul Taylor Novartis has thrown its weight behind a “Cinderella antibody,” leading a 30.8 million pound sterling ($40.9 million) series B round that positions Epsilogen to try to create “a brand new category of pharmaceutical within within cancer.” read more By Max Bayer Sanofi seems to be in a betting mood and has been picking up card after card in licensing deals to bulk up its early-stage pipeline. Now, the French Pharma is putting even more chips down for a tie-up worth a potential $2.5 billion with bispecific antibody producer Adagene. read more By Max Bayer SAB Biotherpeutics' COVID-19 antibody treatment SAB-185 is no longer following in the footsteps of AstraZeneca’s Evushield as the National Institutes of Health has axed a sponsored phase 3 trial citing low COVID-19 hospitalizations. read more By Kyle LaHucik Flagship Pioneering revealed the latest biotech to emerge from its incubator: Vesalius Therapeutics, which begins with $75 million to go after diseases that contribute to 90% of human illness. The ambitious company is being led by former director of the National Institutes of Health's National Center for Advancing Translational Sciences, Christopher Austin, M.D. read more By Kyle LaHucik RedHill Biopharma's COVID-19 pill kept all 41 patients out of the hospital, as compared to three of 20 patients in the placebo arm, and proved safe and tolerable. read more By Max Bayer Epizyme is cutting 12% of its staff and ending two clinical studies, including mid- and early-stage combo trials for the FDA-approved cancer treatment Tazverik, in an effort to cut costs. read more By Kevin Dunleavy Created in 2017 in the name of transparency, Sanofi's annual drug pricing report lays out the latest info on the company's price hikes, rebates and rationale for the cost of new medicines. In the report's latest iteration, Sanofi reveals its price hikes averaged 1.5% last year but that its average net prices fell—once again—by 1.5%. read more By Kevin Dunleavy An interesting and varied group of drugs—ranging from two first-in-class cancer therapies to a treatment that removes frown lines—face target dates for approval this month. Many of the decisions bear watching as their status could have far-reaching implications in the industry and for patients. read more By Conor Hale Johnson & Johnson’s Acuvue Theravision lenses are laden with ketotifen, the same drug used in a variety of eye drops for taming reactions to pollen, grass, pet dander or dust. read more By Andrea Park Amid its recent decision to pump the brakes on the FDA application for its experimental Alzheimer’s drug donanemab, Eli Lilly appears to be casting a wider net in its efforts to improve treatment of the neurodegenerative disease. read more By Robert King President Biden called for a $35 monthly cap on insulin costs and a series of reforms to nursing homes such as staffing requirements during his first State of the Union speech. read more Resources Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Blue Matter What’s in store for the CNS therapeutics market in 2022? This paper looks ahead in Alzheimer’s, Parkinson’s, DMD, psychiatric disorders, pain, and more. Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. 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